MAUDE Adverse Event Report: CONMED LARGO 4.0 X 7.9MM BUR,LONG,BARREL,CARBIDE FOR A211,A235 AND U211; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	L40B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the l40b, 4.0 x 7.9mm bur,long,barrel,carbide for a211,a235 and u211, was being used during an unknown procedure on (b)(6) 23 when it was reported, ¿it was reported that this bur broke while cutting the acetabulum.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment was requested, and the reporter advised that a fragment of the device fell into the patient and was retrieved using a forceps-like device.The procedure was completed as planned using a ¿backup bur¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The evaluation of the returned used device, item l40b found shaft was broken off.Critical dimensions were inspected per print l40b and could not find any discrepancies with machined bur.No defects were found through measurement or examination of the returned product.Suspect, excessive force (load) was used during the procedure.This is a technique dependent device and the most likely cause of this suspected failure is user related.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this excessive force.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: prior to each use, ensure all accessories are correctly and complete attached and perform the required preoperative functional tests for the equipment and accessories.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the l40b, 4.0 x 7.9mm bur, long, barrel, carbide for a211, a235 and u211, was being used during an unknown procedure on (b)(6) 2023 when it was reported, "it was reported that this bur broke while cutting the acetabulum." there was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment was requested, and the reporter advised that a fragment of the device fell into the patient and was retrieved using a forceps-like device.The procedure was completed as planned using a ¿backup bur¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.0 X 7.9MM BUR,LONG,BARREL,CARBIDE FOR A211,A235 AND U211
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18324360
• Report Number: 1017294-2023-00117
• Device Sequence Number: 7358859
• Product Code: GFF
• UDI-Device Identifier: 10845854009741
• UDI-Public: (01)10845854009741(17)280221(30)1(10)1301958
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: L40B
• Device Lot Number: 1301958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic